Posted 19 September 2017
By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Reports 64% Year-on-Year Increase in Regulatory Compliance Investigations
The Therapeutic Goods Administration (TGA) of Australia has reported a 64% increase in regulatory compliance investigations. The year-on-year jump led TGA to issue close to 2,000 warnings, almost twice as many as in the previous reporting period.
TGA completed 2,887 investigations in its 2016-17 reporting year, up from 1,760 the previous year. The rise over 2014-15 is more dramatic. Back then, TGA completed 918 regulatory compliance investigations, meaning the agency has more than tripled its level of activity in three years. The regulator also reported a sharp price in the number of investigations started but not finished as of the end of the year. TGA ended the year with 1,136 investigations ongoing, an increase of 215% over the 2015-16 reporting period.
The increases are a consequence of the Australian Border Force alerting TGA to more imports of unapproved prescription medicines. Like last year, more than half of the TGA investigations were triggered by reports from customs officials in New South Wales, the Australian state that contains Sydney.
Customs officials in New South Wales were largely responsible for the surge in investigations last year. In 2015-16, the state’s border force sent 943 complaints to TGA. Last year, the figure was 2,373. Reports from other states and other stakeholders, such as sponsors and external agencies, also increased, but these rises were dwarfed by the surge in activity in New South Wales.
A similar pattern is evident in TGA’s breakdowns of the types of therapeutic goods and categories of compliance investigations. Investigations into most types of therapeutic good increased but none so much as those into prescription medicines. TGA conducted 142% more investigations into these products. Similarly, most of the additional compliance investigations were categorized as covering unapproved products. The number of these investigations increased 130%, while the rise in cases involving counterfeit products was less than 2%.
TGA presented the data in a report on its activities in 2016-17. The report also included numbers on filings received by the agency and its processing of them. Some of the data provide support for TGA’s decision to change its target time for processing good manufacturing practice clearance applications and revisions to how it handles such filings.
The number of applications received by TGA reached 6,506, up 15% over the record number from the previous year. The proportion of the received applications TGA completed slipped from 95% to 88%, reflecting the agency's struggle to cope with the increased workload.
TGA rejected 642 filings last year, compared to 263 in the previous period. That number could increase further still once the agency implements its new, harder-line stance on incomplete clearance applications.
India to Reassess Cardiac Stent Price Ceiling in February
The National Pharmaceutical Pricing Authority (NPPA) of India will reassess its cap on the price of cardiac stents in February. NPPA is opting against making a mid-term change of the ceiling in favor of reconsidering its position one year after it originally implemented the cap.
The Economic Times broke news of NPPA’s plans, which the price watchdog later confirmed in a post on Twitter. The decision not to reconsider the cap until a full year has passed means medical device makers that have grievances against the ceiling will need to wait months more for possible relief. That could cause consternation among manufacturers affected by the price ceiling, but NPPA thinks the timing is appropriate.
“Next February, stent prices as well as grievances and suggestions would be revisited through a consultative process. At that stage, the government would have a year's experience and [would be better placed to decide] what the new ceiling prices of stents should be and whether some stents need differential pricing,” an anonymous senior government official said.
The lack of higher prices for what manufacturers see as premium products is one controversial aspect of NPPA’s pricing policy. Abbott Healthcare and Medtronic asked to withdraw products from the market but, for a variety of reasons, were told they had to continue supplying the devices.
One of the devices is Abbott’s Absorb GT1 Bioresorbable Vascular Scaffold, which the company has stopped selling in all markets owing to slow sales. NPPA has confirmed Abbott filed a withdrawal request. Abbott will retain an interest in the prices of stents in India even after that withdrawal is complete, though. The company’s original, price-related withdrawal request also covered Xience Alpine Everolimus Eluting Coronary Stent System.
NPPA Post, The Economic Times
Pakistan Proposes Fines, Cancellations of Registrations for Noncompliant Drugmakers
Pakistan has proposed legislative changes that would empower officials to act against companies that breach its rules on drug registration renewals. The draft amendments could lead to fines and cancellations of registrations.
Legislators in Pakistan are proposing to create these new powers through a change to the Drugs (Licensing, Registering and Advertising) Rules, 1976. The centerpiece of the planned amendments is a paragraph detailing what will happen to companies that have failed — and continue to fail — to meet an existing requirement related to the renewal of registrations.
These companies must “deposit three times of their applicable renewal fee for their registration to continue to be valid.” In another scenario, Pakistani officials will charge drug companies a fee “equivalent to applicable renewal fee for each month till one year of the expiry of registration and after one year the registration shall be canceled.”
Anyone who takes issue with the proposed changes can submit comments. The Drug Regulatory Authority of Pakistan will review the comments.
Failure of Publicly Funded Bodies to Clear Regulatory Hurdles Prompts CDSCO Action
India’s Central Drugs Standard Control Organization (CDSCO) has established a system to support drug development at publicly funded institutions. The agency decided such a system was needed after learning a lack of regulatory knowledge has stopped institutions from winning approvals.
CDSCO said some institutions lack a “proper understanding on the laid down regulatory pathways.” This has led to institutions developing drugs without generating the evidence needed to support regulatory approvals, resulting in the wasting of time and the Indian state’s investment in science.
The agency has responded by setting up a “system of consultative meetings” with the affected laboratories and institutions. These meetings will discuss each institution’s drug development programs with a view to educating the teams about how to proceed in a way that enables them to win approvals.
CDSCO has put Shri AK Pradhan, deputy drugs controller, in charge of coordinating the meetings. Experts in the fields in which the institutions are active may also attend.
TGA is preparing to adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE009-13. The agency will adopt the document, which was issued at the start of this year, at the end of December. From then on, TGA inspectors will use the guide as the basis of their assessments of manufacturing facilities. Inspectors will take a “pragmatic approach” to reporting and discussing deficiencies during a transition phase lasting all of 2018. TGA Notice
CDSCO has issued warnings about four products deemed to be not of standard quality. The warning affects three products manufactured by Bhat Biotech and one made by Mediclone Biotech. Bhat Warning, Mediclone Warning